Developing nutraceutical ingredients using pharma approach is a big task

It is good to know that growth in nutrition area is amazing, but the concept of ensuring safety and quality is not yet equally built-in. This is a big challenge. Plenty of nutritional products are in the market as nutritional supplements, functional foods, lifestyle management products, animal health products etc.

The demand is constantly growing but not the quality consciousness. To understand this better, we need to analyse the weaknesses and strengths in present scenario so that innovation can be brought in to improve the product with respect to safety and efficacy. In pharmaceutical industry the regulations are stringent right from development of the product to consumption by customers.

In nutraceuticals (herbals as well as non-herbals) industry the regulations are not that spelt out, which results in inconsistent products in the market. In most of the pharma products, the consumption by consumers is only for the treatment duration. But in nutraceuticals, the consumption is for a longer duration as it is coupled with lifestyle management. Therefore need arises for nutraceutical products with consistent efficacy and safety. Quality and safety need to be incorporated during development stage itself. To develop competent nutraceutical products, innovation and pharmaceutical approach are needed. Innovations can be done if we know the potential areas.

Quality Standards:
There are no stringent quality standards available for herbal products unlike pharmacopeial monographs. Ayurveda recommends use of crude herbs powders, tinctures, churnas, crude extracts etc. These are all not standardised for actives. Quality of herbs can vary a lot due to many factors. This means the expected health benefits are not assured. Therefore standardisation is needed to get consistent quality. Developing monographs for herbs, various types of extracts and finished forms is very essential. This involves innovative planning to isolate marker compounds, developing testing methods, validating methods, stability determining etc.

Each herb and extracts should be studied in depth to specify quality standards, covering impurities relating to physical, chemical, biological in addition to purity parameters, similar to pharmacopeial products. This should cover the dosage, expiry dating, and compatibility parameters in multiple ingredients formula as well.

Concept of delivering herbal ingredients with pharmaceutical model by adapting innovative technology is the key for consumer safety. This assures quality consistency in herbal ingredients where official pharmacopeial monographs are not available. In India AYUSH has taken steps to develop herbal monographs. Green Chem is part of this programme. USP, India has also initiated monograph development for nutraceuticals. Green Chem is planning to participate in the USP programme.

Testing of products should include herb identification (botany, chemistry), physiochemical parameters, organoleptic properties, assay of active phyto-compounds, heavy metals, residual solvents, residual pesticides, organic volatiles, microbial tests, stability monitoring, impurity profiling, compatibility with other combinations, stability and expiration dating etc.

Develop new products and improve existing products:
In addition to quality consistency, innovation is also needed to overcome competition by way of introducing new products to tackle current ailments and to improve old products. New products can be for improved efficacy, reduced costing, multiple benefits, avoidance of side effects etc.

Innovation can be done in new product identification, herb selection, extraction methods, testing methods, packaging, formulations, marketing concepts etc.

Innovative concepts:
New innovative concepts like use of synergy to boost the efficacy, multiple formula can help support humans and animals. Green Chem has developed a new product which has multiple benefits to control sugar, to reduce LDL cholesterol, to increase HDL cholesterol, to improve liver functions and few others. Green Chem has also developed few other products with new concepts for joint care, osteoporosis and hair growth. These products will be launched in 2015-2016.

Another area of innovation is the use of multiple herbal extracts to exploit synergy in areas like anti-ischemia, female libido enhancing, male libido enhancing, anti-obesity and psoriasis. Innovative concepts are possible in delivering the product as nano particles, dermal patches, preventive formula, organic herbal ingredients etc.

Confirming safety:
It is essential to confirm safety of nutraceutical products by pharma approach.

The bioactivity and safety of the product should be confirmed by pre-clinical studies. Suitability for human consumption should be ensured by double blind, randomised, placebo controlled study as per requirement. Mechanism of action of the product needs to be established to know more about the product. It should be ensured nontoxic by conducting various toxicity studies. Toxicity study should be carried out elaborately covering acute oral toxicity, mutagenicity and sub-chronic toxicity and teratogenicity.

Efficacy confirmation and dosage levels should be established.

Complimentary medicines:
Complimentary medicines are the new innovative approach, being attempted to get the benefits of natural and pharma products in supplements industry. Using synthetic pharma products to reduce the sugar levels to normal level and then switching over to herbal extracts to maintain the sugar levels is the new approach to reduce long-term side effects.

Herbs can give lot of variety and flexibility in usage. Gymnema herb is an anti-diabetic herb. The mechanism of working is unique! This is to be taken before a meal so that the gymnemic acids present in gymnema, obtunds sugar identifying receptors temporarily when the sugar is passing through the alimentary canal. Therefore entry of sugar into blood stream is limited. Taking gymnema before meal and taking other herbal extracts after the meal can regulate sugar levels. Green Chem is developing this concept with DiaBef and DiaAft for sugar control.

Herbal extracts can work better at a different platform as compared to pharma products. Synthetic drugs can help in controlling the disease and thereafter herbal extracts can take over to maintain the control. The inter phase has to be gradual to avoid possible imbalance due to sudden abrupt change over. By this way long use of synthetic drugs can be minimised with lesser side effects. Regulatory bodies should consider careful handling of this issue. Innovation and patent protection are essential for safeguarding business stability.

Innovation means newness and that should be properly validated for safety of children, adults and animals. The scope for developing innovative nutraceutical ingredients using pharma approach is very big. It is important to establish the safety and efficacy first and then market it.

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